Rheumatoid ArthritisPhase 3ReActNCT00448383
A Study to Assess the Safety and Efficacy of Adalimumab When Added to Inadequate Standard Anti-Rheumatic Therapy in Patients With Active Rheumatoid Arthritis
A Phase 3 study testing adalimumab in people with Rheumatoid Arthritis, run by Abbott.
Trial summary
This is an open-label, multi-center study in which adalimumab (D2E7) is administered subcutaneously 40 mg every other week in addition to current anti-rheumatic therapies. Patients must have active disease despite standard anti-rheumatic therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- adalimumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6,610 participants
- Where
- No sites listed yet
- Study dates
- Sep 2002to Nov 2004
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must be 18 years or older
- ACR criteria for diagnosis of RA for at least 3 months.
- Active RA as defined by DAS28 >= 3.2 at study entry.
- Unsatisfactory response or intolerance to prior DMARDs.
- A negative pregnancy test (serum HCG) for women of childbearing potential prior to start of study treatment.
- Use of reliable method of contraception e.g. IUDs, condoms, or hormone (oral, implantable, or injectable) contraceptives by all female patients of childbearing potential. Male patients with procreative capacity should also ensure that effective contraception is used during the study and for 70 days after study completion
Who cannot join
- Prior treatment with alkylating agents such as cyclophosphamide or chlorambucil.
- Prior treatment with intravenous immunoglobulin or any investigational agent within 30 days, or 5 half lives of the product, whichever is longer.
- Prior treatment with investigational biologic therapy (e.g. anti CD4)
- Treatment within the last 2 months with approved biologic therapy (eg etanercept, infliximab, anakinra)
- Prior treatment with total lymphoid irradiation
- History of cancer or lymphoproliferative disease other than a successfully and completely treated squamous cell or basal cell carcinoma.
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- History of or current acute inflammatory joint disease of origin other than RA, e.g. mixed connective tissue disease, systemic lupus erythematosus etc.
- History of uncontrolled diabetes, unstable ischemic heart disease, active inflammatory bowel disease, active peptic ulcer disease, recent stroke (within 3 months) and any other condition which, in the opinion of the investigator, would put the subject at risk by participation in the protocol.
- Positive serology for hepatitis B or C indicating active infection
- History of positive HIV status.
- Persistent infection, or severe infections requiring hospitalization or treatment with iv antibiotics within 30 days, or oral antibiotics within 14 days prior to enrollment.
- Female subjects who are pregnant or breast-feeding.
- History of clinically significant drug or alcohol abuse in the last year.
- Previous diagnosis or signs of demyelinating diseases
- History of active tuberculosis (TB), histoplasmosis or listeriosis.
- Signs of previous TB infection (chest X-ray signs or positive PPD skin test). The diagnosis of previous TB infection will be based on chest X-ray signs and on PPD skin test.
About this study
Official title: An Open-Label, Multi-Center Study to Assess the Safety and Efficacy of the Fully Human Anti-TNF-α Monoclonal Antibody Adalimumab (D2E7) When Added to Inadequate Standard Anti-Rheumatic Therapy in Patients With Active Rheumatoid Arthritis
This is an open-label, multi-center study in which adalimumab (D2E7) is administered subcutaneously 40 mg every other week in addition to current anti-rheumatic therapies. Patients must have active disease despite standard anti-rheumatic therapy.
- Conditions
- Rheumatoid Arthritis
- Being tested
- adalimumab
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
adalimumabBiological
Also called ABT-D2E7, Humira
40mg every other week
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Open-label adalimumab Receives: Biological: adalimumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of disease activity score (DAS28) compared with study entry
Measured: Week 12
EULAR and ACR response criteria at week 12
Measured: Week 12
Secondary outcomes (2)
Adverse events
Measured: Baseline - Week 12
Clinical laboratory parameters
Measured: Screening, Week 6 & Week 12 and/or ET
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2007 (estimated)
- Study startSep 2002
- Primary completionNov 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6,610 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Beverly Paperiello, Study director, Abbott
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00448383
- Sponsor's protocol ID
- M02-497
- Acronym
- ReAct
- Status last verified
- Jul 2008
- First submitted
- 14 Mar 2007
- Last updated
- 4 Aug 2008
- Results posted
- No
Publications
Burmester GR, Landewe R, Genovese MC, Friedman AW, Pfeifer ND, Varothai NA, Lacerda AP. Adalimumab long-term safety: infections, vaccination response and pregnancy outcomes in patients with rheumatoid arthritis. Ann Rheum Dis. 2017 Feb;76(2):414-417. doi: 10.1136/annrheumdis-2016-209322. Epub 2016 Jun 23.
PubMed 27338778Burmester GR, Matucci-Cerinic M, Mariette X, Navarro-Blasco F, Kary S, Unnebrink K, Kupper H. Safety and effectiveness of adalimumab in patients with rheumatoid arthritis over 5 years of therapy in a phase 3b and subsequent postmarketing observational study. Arthritis Res Ther. 2014 Jan 27;16(1):R24. doi: 10.1186/ar4452.
PubMed 24460746Burmester GR, Ferraccioli G, Flipo RM, Monteagudo-Saez I, Unnebrink K, Kary S, Kupper H. Clinical remission and/or minimal disease activity in patients receiving adalimumab treatment in a multinational, open-label, twelve-week study. Arthritis Rheum. 2008 Jan 15;59(1):32-41. doi: 10.1002/art.23247.
PubMed 18163417
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Multi-Center Study to Assess the Safety and Efficacy of the Fully Human Anti-TNF-α Monoclonal Antibody Adalimumab (D2E7) When Added to Inadequate Standard Anti-Rheumatic Therapy in Patients With Active Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT00448383
- Acronym / sponsor ID
- ReAct / M02-497
- Conditions
- Rheumatoid Arthritis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6,610 participants (actual)
- Lead sponsor
- AbbottIndustry (pharma, biotech, devices)
- Study start
- Sep 2002
- Primary completion
- Nov 2004 (actual)
- First posted
- 16 Mar 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open-label, multi-center study in which adalimumab (D2E7) is administered subcutaneously 40 mg every other week in addition to current anti-rheumatic therapies. Patients must have active disease despite standard anti-rheumatic therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Biological: adalimumabOpen-label adalimumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subjects must be 18 years or older
- ACR criteria for diagnosis of RA for at least 3 months.
- Active RA as defined by DAS28 >= 3.2 at study entry.
- Unsatisfactory response or intolerance to prior DMARDs.
- A negative pregnancy test (serum HCG) for women of childbearing potential prior to start of study treatment.
Key exclusion criteria (16 listed)
- Prior treatment with alkylating agents such as cyclophosphamide or chlorambucil.
- Prior treatment with intravenous immunoglobulin or any investigational agent within 30 days, or 5 half lives of the product, whichever is longer.
- Prior treatment with investigational biologic therapy (e.g. anti CD4)
- Treatment within the last 2 months with approved biologic therapy (eg etanercept, infliximab, anakinra)
- Prior treatment with total lymphoid irradiation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| adalimumabAlso: ABT-D2E7, Humira40mg every other week | Biological | 1 |
Primary outcome
Change of disease activity score (DAS28) compared with study entry
Time frame: Week 12
EULAR and ACR response criteria at week 12
Time frame: Week 12
2 secondary outcomes
Adverse events
Time frame: Baseline - Week 12
Clinical laboratory parameters
Time frame: Screening, Week 6 & Week 12 and/or ET
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2008.
- Derived from this study: PubMed 27338778Burmester GR, Landewe R, Genovese MC, Friedman AW, Pfeifer ND, Varothai NA, Lacerda AP. Adalimumab long-term safety: infections, vaccination response and pregnancy outcomes in patients with rheumatoid arthritis. Ann Rheum Dis. 2017 Feb;76(2):414-417. doi: 10.1136/annrheumdis-2016-209322. Epub 2016 Jun 23.
- Derived from this study: PubMed 24460746Burmester GR, Matucci-Cerinic M, Mariette X, Navarro-Blasco F, Kary S, Unnebrink K, Kupper H. Safety and effectiveness of adalimumab in patients with rheumatoid arthritis over 5 years of therapy in a phase 3b and subsequent postmarketing observational study. Arthritis Res Ther. 2014 Jan 27;16(1):R24. doi: 10.1186/ar4452.
- Derived from this study: PubMed 18163417Burmester GR, Ferraccioli G, Flipo RM, Monteagudo-Saez I, Unnebrink K, Kary S, Kupper H. Clinical remission and/or minimal disease activity in patients receiving adalimumab treatment in a multinational, open-label, twelve-week study. Arthritis Rheum. 2008 Jan 15;59(1):32-41. doi: 10.1002/art.23247.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Beverly Paperiello study director
Abbott
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing adalimumab in people with Rheumatoid Arthritis, run by Abbott.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Aug 2008. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of disease activity score (DAS28) compared with study entry (time frame: Week 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00448383, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2008.